Gastroparesis in type2 Diabetic Patient

Not yet recruiting

• Conditions: Diabetic Gastroparesis

• Registration Number: NCT05584462
• Lead Sponsor: Assiut University

Brief Summary

Gastroparesis is defined by objective delaying of gastric emptying without any evidence of mechanical obstruction. Diabetic gastroparesis is a potential complication that occurs in the setting of poorly controlled diabetes, resulting from dysfunction in the coordination and function of the autonomic nervous system, neurons, and specialized pacemaker cells (interstitial cells of Cajal, ICC) of the stomach and intestine, and the smooth muscle cells of the gastrointestinal tract

Detailed Description

Hyperglycemia (random blood glucose greater than 200 mg/dL), commonly seen in uncontrolled diabetes, has been associated with diabetic gastroparesis resulting from neuropathy in the setting of chronic hyperglycemia and does not resolve with improved glycemic control. Acute hyperglycemia, on the other hand, though it can also result in delayed gastric emptying, is often reversible with improved glycemic control. Although there is a stronger association between type 1 diabetes and gastroparesis, the incidence of type 2 diabetes is much greater, and therefore, gastroparesis associated with type 2 diabetes is seen more frequently. Additionally, incretin mimetics are used to treat patients with type 2 diabetes, and these medications pose an additional risk factor for developing gastroparesis.Gastric emptying scintigraphy (GES) is the investigation of choice for evaluating the disorders of gastric emptying because it is a simple, physiological, and sensitive investigation to objectively assess gastric emptying. Standard imaging is performed at 0,1,2,4 hours postprandially. A four-hour study is more sensitive and accurate in diagnosing gastroparesis, and clinicians should avoid shortened 2- and 3-hour studies.

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-15
• Study First Posted: 2022-10-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17
• Study Start: 2023-11-01
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Type 2 DM
2. Age < 40 years
3. >5 years of DM

Exclusion Criteria

1. Type 1 DM
2. History of GIT surgry
3. Medical disease affect gastric emptying
4. Using of prokinetic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of gastroparesis in type 2 diabetic patients	3 years

Secondary Outcome Measures

Name	Time	Method
Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis	3 years	using of Gastric emptying scintigraphy as a tool for diagnosis of gastroparesis